Aquestive Therapeutics, Inc. - AQST STOCK NEWS

Aquestive Therapeutics has announced that the FDA has conditionally accepted the proprietary name Anaphylm™ for its investigational product AQST-109, a sublingual film designed to treat severe allergic reactions, including anaphylaxis. This name, which connects to anaphylaxis and emphasizes its film form, was developed through extensive market research, including healthcare professional feedback. With an estimated 49 million Americans at risk of anaphylaxis, the company aims to improve patient access and usage of its product. Anaphylm's acceptance is contingent upon FDA approval of AQST-109. The product is designed to be portable and easy to use, representing a significant advancement in anaphylaxis treatment.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its first quarter results and business updates will be released after market close on May 2, 2023. A conference call for investors is scheduled for May 3, 2023, at 8:00 a.m. ET, where management will discuss the results and insights into recent developments. Interested participants can register for the call online. A live webcast will also be available on the company's website, with a replay accessible for 30 days afterward. Aquestive focuses on developing innovative orally administered medications to improve patient care, particularly in central nervous system diseases and severe allergic reactions. The company has five commercialized products and is advancing its proprietary product pipeline, utilizing proprietary technologies like PharmFilm®.

Aquestive Therapeutics (NASDAQ: AQST) announced the expansion of its exclusive license and supply agreement with Atnahs Pharma UK Limited for Libervant™ (diazepam) Buccal Film, now covering more territories outside the U.S., Canada, and China. Originally announced in September 2022, this agreement aims to improve patient access to the product globally. Aquestive will be the exclusive manufacturer, while Pharmanovia oversees regulatory and commercialization efforts. The partnership includes an undisclosed upfront payment, potential milestone payments, and double-digit royalties on net sales. Libervant is designed for acute treatment of seizure clusters in epilepsy patients aged 12 and older.

Aquestive Therapeutics (AQST) announced its 2022 financial results and 2023 outlook, focusing on key initiatives, including the pivotal study for AQST-109, an epinephrine sublingual film, expected to start in Q3 2023. The company achieved an 18% reduction in outstanding debt and secured $20 million in non-dilutive capital in Q1 2023. Total revenues for 2022 were $47.7 million, down 6% year-over-year, with a net loss of $54.4 million. Despite some revenue declines, the company anticipates a revenue range of $37 to $41 million in 2023, excluding proprietary net sales from Sympazan. A conference call is scheduled for March 8, 2023.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its participation in the Oppenheimer 33rd Annual Healthcare Conference from March 13-15, 2023. The management team will present on March 13 at 4:40 pm ET and will engage in investor meetings throughout the conference. A webcast of the presentation will be available on the company's website, with a replay accessible for 30 days post-event. Aquestive focuses on developing innovative medicines to improve patient quality of life and has five commercial products marketed worldwide. The company continues to advance its drug pipeline aimed at treating central nervous system diseases and severe allergic reactions.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced it will report its fourth-quarter results for 2022 after the market closes on March 7, 2023. The company will also provide an update on recent business developments. Following the announcement, management will host a conference call for investors at 8:00 a.m. ET on March 8, 2023. Interested participants may register in advance for access. This call will be supplemented by a live webcast available on the company’s website. Aquestive focuses on advancing pharmaceuticals to improve patient care, including a late-stage pipeline for central nervous system diseases and early-stage treatments for severe allergic reactions.

Aquestive Therapeutics (NASDAQ: AQST) announced the presentation of four late-breaking posters at the AAAAI annual meeting from February 24-27 in San Antonio, Texas. The posters will showcase positive data from pharmacokinetic and pharmacodynamic studies of AQST-109, a sublingual epinephrine film aimed at treating acute allergic reactions. Dan Barber, CEO, expressed excitement about the data's potential to revolutionize anaphylaxis treatment, pending FDA approval. Notable studies include comparisons between AQST-109 and traditional epinephrine injections, demonstrating faster onset and efficacy parameters. Anaphylaxis poses risks to 49 million Americans, highlighting a significant healthcare need.

Aquestive Therapeutics (AQST) has outlined key initiatives for 2023, focusing on advancing AQST-109 into pivotal trials and pursuing FDA accelerated market access for Libervant™. The company anticipates approximately $27 million in cash as of December 31, 2022. The pivotal pharmacokinetic trial for AQST-109 is expected in the second half of 2023, targeting a potential launch in 2025. With ongoing collaborations and increased manufacturing capabilities, Aquestive aims to enhance its market position and patient outcomes.

Aquestive Therapeutics (AQST) announced a successful End-of-Phase 2 meeting with the FDA regarding AQST-109, a sublingual film for severe allergic reactions. The FDA indicated that efficacy studies may not be necessary, instead favoring a comparability study. The guidance emphasizes pharmacokinetic performance aligned with existing injectable epinephrine products. Aquestive aims for a New Drug Application (NDA) submission in the first half of 2024 and anticipates a product launch in 2025.